Aging, Cardiac Disease, Physical Activity
Conditions
Brief summary
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)
Detailed description
Study Type: observational, investigator led Study Design: observational model: cohort (retrospective) Population: 150 people over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Data collection: daily PA measures, demographic details, co-morbidity status, physical frailty assessment, functional status, quality of life (QOL) and NEHA data Consent: for participation in the study, physical frailty assessment, additional collection of retrospective CIED data, and access to electronic patient records Data sources: CIED downloads, self-report questionnaire, physical measurements (height, weight, hand grip strength, gait speed), electronic hospital records, HES (hospital episode statistics) data Results analysis: data will be analysed to investigate: daily PA variability; the association between PA and NEHAs, and the impact of frailty on PA patterns
Interventions
OTHERNo intervention
No intervention
Sponsors
University of Manchester
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 60+ years 2. Functioning CIED in situ for at least 6 months 3. Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters) 4. Lives in the Greater Manchester area 5. Able and willing to given written, informed consent to enter the study
Exclusion criteria
1. Faulty or incompatible device 2. Immobile (unable to walk in upright position) 3. Active participant in a clinical trial which does not allow concurrent recruitment into this study 4. People unable to consent in the English language (including the understanding of study literature which is published in English only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-elective Hospital Admissions | Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment) | Non-elective hospital admissions, as defined as an emergency admission to an National Health Service (NHS) hospital within England or Wales for any reason. Data collected from NHS England. Number of Participants With Non-elective Hospital Admissions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frailty | 30 days | Frailty as per Fried criteria Fried frailty criteria is a score between 1-5. A score of 0-1 = not frail A score of 2 = pre-frail A score of 3+ = frailty Reference: Fried, L. P., Tangen, C. M., Walston, J., Newman, A. B., Hirsch, C., Gottdiener, J., ... & McBurnie, M. A. (2001). Frailty in older adults: evidence for a phenotype. The journals of gerontology series a: biological sciences and medical sciences, 56(3), M146-M157. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Cohort People over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK
No intervention: No intervention | 183 |
| Total | 183 |
Baseline characteristics
| Characteristic | Study Cohort |
|---|---|
| Age, Continuous | 73 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United Kingdom | 183 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 183 |
| other Total, other adverse events | 0 / 183 |
| serious Total, serious adverse events | 0 / 183 |
Outcome results
Primary
Non-elective Hospital Admissions
Non-elective hospital admissions, as defined as an emergency admission to an National Health Service (NHS) hospital within England or Wales for any reason. Data collected from NHS England. Number of Participants With Non-elective Hospital Admissions.
Time frame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)
Population: People over 60 years with compatible implanted cardiac device
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low Activity | Non-elective Hospital Admissions | Non-elective hospitalisation | 2 Participants |
| Low Activity | Non-elective Hospital Admissions | No non-elective hospitalisation | 31 Participants |
| Medium/High Activity | Non-elective Hospital Admissions | No non-elective hospitalisation | 104 Participants |
| Medium/High Activity | Non-elective Hospital Admissions | Non-elective hospitalisation | 3 Participants |
Secondary
Frailty
Frailty as per Fried criteria Fried frailty criteria is a score between 1-5. A score of 0-1 = not frail A score of 2 = pre-frail A score of 3+ = frailty Reference: Fried, L. P., Tangen, C. M., Walston, J., Newman, A. B., Hirsch, C., Gottdiener, J., ... & McBurnie, M. A. (2001). Frailty in older adults: evidence for a phenotype. The journals of gerontology series a: biological sciences and medical sciences, 56(3), M146-M157.
Time frame: 30 days
Population: 140 participants had adequate activity data from devices
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low Activity | Frailty | Frailty | 16 Participants |
| Low Activity | Frailty | Pre-frailty | 74 Participants |
| Low Activity | Frailty | Not frail | 50 Participants |